- The Trump reelection campaign has postponed Vice President Mike Pence’s upcoming events in Arizona and Florida out of an “abundance of caution” as those states — among others — see their COVID-19 cases spike.
- The vice president on Friday falsely claimed the US had flattened the curve despite contradictory evidence from the White House Coronavirus Task Force.
- On Friday, the US reported more than 40,000 new COVID-19 cases — the highest single-day increase reported since the pandemic began.
- Visit Business Insider’s homepage for more stories.
The campaign for President Donald Trump’s re-election on Saturday postponed upcoming events in both Arizona and Florida as both states report record increases in COVID-19 cases.
The campaign said it was postponing Vice President Mike Pence’s scheduled campaign stops in the states “out of an abundance of caution,” according to NBC News reporter Josh Lederman. Business Insider confirmed that Pence’s events have been postponed.
Pence is still expected to visit both Arizona and Florida to meet with state leaders, but the meetings will be considered White House events and not campaign stops, according to NBC News’ Jacob Gardenswartz.
The move comes one day after a press conference where the vice president falsely claimed that the US had flattened the curve as the nation reported its highest single-day increase in new cases of all time.
“As we stand here today, all 50 states and territories across this country are opening up safely and responsibly,” Pence said Friday after a meeting with the White House Coronavirus Task Force. “The truth is, we did slow the spread. We flattened the curve.”
As Business Insider previously reported, 14 charts from the White House’s own task force showed that the spread of COVID-19 was quickly increasing, particularly among heavily populated areas in southern states. Some leaders, including the president, have blamed increases on increased testing capacity, though experts have said that’s not accurate as states like Texas and Florida have reported a higher share of positives among test results, Business Insider’s Aylin Woodward noted.
Florida and 10 other states broke their records for the average number of cases reported daily over the past week, according to The Washington Post. At least 40,173 new COVID-19 cases were reported on Friday, according to CNN via data analyzed by Johns Hopkins University. Other estimates were higher. NBC News found that more than 45,000 new cases of COVID-19 were reported nationwide on Friday.
On Saturday, Arizona reported 3,591 new cases, tying its all-time record set on Tuesday, according to the Arizona Department of Health Services. On Friday, Florida broke its all-time record with nearly 9,000 reported new cases of COVID-19. As Business Insider previously reported, that was the highest single-day increase reported by any US state since April 15.
While the campaign has postponed Pence’s events, the president on June 20 held an in-person rally in Tulsa, Oklahoma against the advice of health experts. The event had at least 6,200 attendees, though the Trump campaign claimed about double that attended. It was Trump’s first campaign event since the COVID-19 pandemic gripped the US and forced him to pause his famed Make American Great Again rallies.
George Soros Buys Millions’ Worth of Stocks Linked to Bill Hwang’s Archegos Collapse: Bloomberg
George Soros reportedly snapped up stocks that took a hit amid the collapse of Archegos Capital Management in March.
What Happened: Billionaire George Soros’ investment firm Soros Fund Management bought shares of CBS Corporation (NASDAQ:VIAC), DISCOVERY COMMUNICATIONS INC (NASDAQ:DISCA) and Baidu Inc (NASDAQ:BIDU) as these stocks were at a discount after Bill Hwang’s Archegos Capital Management collapsed, Bloomberg reports.
Soros bought $194 million in ViacomCBS shares and $77 million in Baidu shares, the report said. The firm also bought $46 million worth of Vipshop Holdings Ltd (NYSE:VIPS) shares and $34 million of Tencent Music Entertainment Group’s (NYSE:TME) shares.
A person familiar with the fund’s trading told Bloomberg that the company didn’t hold the shares before Archegos’ implosion.
Why It Matters: Hwang ran a family office that imploded in March and caused massive losses at a few big banks when Archegos couldn’t meet margin calls. Archegos had more than $20 billion of capital and total bets exceeding $100 billion.
Hwang was very successful with his family office until he began to overutilize leverage, or borrowed money, to chase higher returns in the market. The problem with this strategy comes when investments start to lose money, and the banks lending the investor money begin to get nervous and initiate margin calls.
Subsequently, shares of Archegos investments ViacomCBS, Discovery and others temporarily crashed during the Archegos unwinding.
Image Credit: CC BY 2.5, Wikimedia Commons
VIVO Clinic Unveils New Travel Information Portal
Leading PCR test provider VIVO Clinic has launched a travel information portal to assist with international trips to and from the UK.
BIRMINGHAM, England, May 16, 2021 /PRNewswire/ — During the pandemic, travel has been severely restricted. Now that the Government has launched a traffic light system designation for every country, UK residents are once again beginning to book holidays for the future.
The travel information portal is a comprehensive resource that provides relevant travel information in one place.
Travellers can browse countries based on the current traffic light designation and live popularity.
When viewing specific countries, travellers can see:
- Which tests are required before, during, and after their trip
- Current restrictions in that country
- Weather, currency conversion, and time difference
- Up to date Covid-19 statistics for that location
- Flight and hotel availability
Commenting on the new system, Will Andrews, CTO at VIVO Clinic says: “International travel is set to bounce back in a big way, but understanding current restrictions and requirements can be confusing, and planning a trip can involve a time-consuming slog through many resources.”
The system automatically aggregates hundreds of data sources to provide information for 330 countries.
“We are incredibly proud of our travel information portal and hope that it will simplify international travel so customers can book trips confidently and safely.”
0333 305 8486
Covid-19 Travel Portal
Travel information portal on iPad
FGEN ALERT: Kessler Topaz Meltzer & Check, LLP Reminds Investors of Securities Fraud Class Action Lawsuit Filed Against FibroGen, Inc. – Expanded Class Period
RADNOR, Pa., May 16, 2021 /PRNewswire/ — The law firm of Kessler Topaz Meltzer & Check, LLP announces that securities fraud class action lawsuits have been filed in the United States District Court for the Northern District of California against FibroGen, Inc. (NASDAQ: FGEN) (“FibroGen”) on behalf of those who purchased or acquired FibroGen securities and/or sold put options from October 18, 2017 through April 6, 2021, inclusive (the “Class Period”).
Investor Deadline Reminder: Investors who purchased or acquired FibroGen securitiesand/or sold put optionsduring the Class Period may, no later than June 11, 2021, seek to be appointed as a lead plaintiff representative of the class. For additional information or to learn how to participate in this litigation please contact Kessler Topaz Meltzer & Check, LLP: James Maro, Esq. (484) 270-1453 or Adrienne Bell, Esq. (484) 270-1435; toll free at (844) 887-9500; via e-mail firstname.lastname@example.org; orclick https://www.ktmc.com/fibrogen-class-action-lawsuit?utm_source=PR&utm_medium=Link&utm_campaign=fibrogen
FibroGen is a biopharmaceutical company that develops medicines for the treatment of anemia, fibrotic disease, and cancer. Its most advanced product is roxadustat (“Roxa”), an oral small molecule inhibitor of hypoxia-inducible factor-prolyl hydroxylase activity that acts by stimulating the body’s natural pathway for red cell production.
The Class Period commences on October 18, 2017 when FibroGen announced that the China Food and Drug Administration (“CFDA”) had accepted its new drug application (“NDA”) for Roxa based on two Phase 3 studies in China, “one study in CKD [chronic kidney disease] comparing roxadustat against a branded epoetin alfa and one study in CKD non-dialysis comparing roxadustat against placebo.” Both studies had “met their primary efficacy endpoints with no new or unexpected safety signals identified.” FibroGen touted these studies’ positive safety throughout the Class Period.
Having overcome the hurdle of demonstrating to the CFDA that Roxa was safe enough to submit an NDA, FibroGen proceeded to present itself as ready to conduct Phase 3 trials sufficient to support an NDA to the U.S. Food and Drug Administration (“FDA”). In 2019, FibroGen filed its NDA with the FDA for the approval of Roxa for the treatment of anemia due to CKD.
The truth began to emerge on March 1, 2021 when, after the market closed, FibroGen announced that the FDA was scheduling an advisory committee meeting to review Roxa’s NDA, well over a year after its initial submission. An advisory committee meeting this late in the review process indicates that there is a problem with the application, and could, at best, delay the FDA’s approval decision and at worst signal that the FDA may not approve the drug. Following this news, FibroGen’s stock price fell by $12.46 per share, or 25%.
Then, on April 6, 2021, after the market closed, FibroGen issued a press release that revealed that FibroGen’s previously disclosed safety data included undisclosed post-hoc changes to the stratification factors and did not include analyses based on the pre-specified stratification factors. As a result of these changes, the complaint alleges that FibroGen was forced to concede that Roxa, contrary to prior representations, did not reduce the risk of cardiovascular events or hospitalization as compared to a currently approved anemia injection used as a control based on pre-specified stratification factors. Following this news, FibroGen’s stock price fell $14.90, or 43%, to close at $19.74 per share on April 7, 2021.
The complaint alleges that throughout the Class Period, the defendants made false and/or misleading statements or failed to disclose that: (1) based on the safety data from FibroGen’s two Phase 3 trials in China, any safety data obtained from the global Phase 3 trials would require post-hoc changes to the stratification factors to meet the FDA’s requirements; (2) FibroGen’s disclosures of U.S. primary cardiovascular safety analyses from the Roxa global Phase 3 program for the treatment of anemia submitted in connection with CKD included post-hoc changes to the stratification factors; (3) FibroGen’s analyses with the pre-specified stratification factors resulted in higher hazard ratios (point estimates of relative risk) and 95% confidence intervals; (4) based on these analyses, FibroGen could not conclude that Roxa reduces the risk of (or is superior to) MACE+ in dialysis, and MACE and MACE+ in incident dialysis compared to epoetin-alfa; (5) as a result, FibroGen faced significant uncertainty that its NDA for Roxa as a treatment for anemia of CKD would be approved by the FDA; and (6) as a result of the foregoing, the defendants’ statements about FirboGen’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.
FibroGen investors may, no later than June 11, 2021, seek to be appointed as a lead plaintiff representative of the class through Kessler Topaz Meltzer & Check, LLP or other counsel, or may choose to do nothing and remain an absent class member. A lead plaintiff is a representative party who acts on behalf of all class members in directing the litigation. In order to be appointed as a lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not affected by the decision of whether or not to serve as a lead plaintiff.
Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.
Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
Adrienne Bell, Esq.
280 King of Prussia Road
Radnor, PA 19087
(844) 887-9500 (toll free)
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SOURCE Kessler Topaz Meltzer & Check, LLP
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New Meta-Analysis of Patients with Acute Coronary Syndrome Shows Nearly Half of Recurrent Major Adverse Cardiovascular Events at One Year Occur Within the First 90 Days
KING OF PRUSSIA, Pa., May 16, 2021 /PRNewswire/ — Global biotherapeutics leader CSL Behring today announced the results of a new meta-analysis of seven interventional Phase 3 clinical trials that included more than 82,000 high-risk patients with recent acute coronary syndrome (ACS). The findings show that 49 percent of the recurrent major adverse cardiovascular events (MACE) experienced in the first year following an ACS event occurred within the first 90 days. The results were presented at the American College of Cardiology’s 70th Annual Scientific Session & Expo (ACC.21).
ACS describes a range of conditions with clinically obstructive coronary disease, where unstable or vulnerable plaque erosion or rupture may block an artery and restrict blood flow to the heart.1,2 While it is largely understood that, despite optimal clinical therapy, patients with ACS are at a high risk of experiencing a recurrent cardiovascular (CV) event within one year, recent research suggests the first 90 days may be the most critical time period.3
“While we know that patients with ACS are always going to be vulnerable for future cardiovascular complications, what is striking is that when we look at all of the recurrent events that occur within one year after ACS, about half are happening within just the first 90 days,” stated C. Michael Gibson, M.D., M.S., an interventional cardiologist at Beth Israel Deaconess Medical Center and principal study investigator. “These data tell us that we need to look beyond our traditional 30-day window in clinical studies and address the underlying cause of these early recurrent events to help provide our patients with more protection.”
Researchers performed a comprehensive search to collect data from Phase 3 interventional trials on high-risk ACS patients. A total of 82,727 high-risk patients with recent ACS from the seven trials were analyzed. Pooled rates of recurrent MACE were 4.1 percent (95% CI: 3.0%-5.7%) at 90 days and 8.3 percent (95% CI: 7.1%-9.8%) at 360 days. Approximately 49 percent of events occurred within the first 90 days.
“This meta-analysis reaffirms that the first 90 days after an ACS event are when patients are particularly vulnerable for recurrent MACE,” said Larry Deckelbaum, Vice President, Research and Development, Cardiovascular and Metabolic Therapeutic Area at CSL Behring. “Despite the treatment options available today, it is clear that more needs to be done to protect patients during this critical time period. That’s why we’re looking towards our novel Phase 3 research program to better understand this risk period and how we can deliver on our promise to patients and reduce the risk of these recurrent events.”
The AEGIS-II study is a Phase 3, multicenter, double-blind, randomized, placebo-controlled, parallel-group study, which will enroll approximately 17,400 patients from 49 countries. It will evaluate the efficacy and safety of CSL112 compared to placebo in reducing the risk of MACE in patients following a heart attack. The primary efficacy outcome is time to the first occurrence of the MACE composite, which includes cardiovascular death, heart attack or stroke, from randomization through 90 days.
About CSL Behring
CSL Behring is a global biotherapeutics leader driven by its promise to save lives. Focused on serving patients’ needs by using the latest technologies, the company develops and delivers innovative therapies that are used to treat coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease, and neurological disorders. The company’s products are also used in cardiac surgery, burn treatment and to prevent hemolytic disease of the newborn.
CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. The parent company, CSL Limited (ASX:CSL;USOTC:CSLLY), headquartered in Melbourne, Australia, employs more than 27,000 people worldwide, and delivers its life-saving therapies to people in more than 100 countries. For inspiring stories about the promise of biotechnology, visit Vita at CSLBehring.com/vita and follow us on Twitter.com/CSLBehring.
Natalie de Vane
SOURCE CSL Behring
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SOURCE CSL Behring
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